Clinical Trial Results:
A Phase 1, Single Dose, 4-Period Crossover Study to Assess the Bioavailability of an Mirabegron Oral Suspension Relative to the Mirabegron Prolonged Release Tablet and to Assess the Effect of Food on the Pharmacokinetics of Mirabegron Oral Suspension in Healthy Young Male and Female Subjects
Summary
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EudraCT number |
2014-001446-24 |
Trial protocol |
DE |
Global end of trial date |
21 Jan 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Aug 2016
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First version publication date |
18 Aug 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
178-CL-201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Astellas Pharma Europe BV
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Sponsor organisation address |
Sylviusweg 62, Leiden, Netherlands, 2333 BE
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Public contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
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Scientific contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000597-PIP03-15 EMEA-000597-PIP02-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jan 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jan 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the bioavailability of 50 mg mirabegron oral suspension relative to that of the
50 mg mirabegron modified release tablet when dosed under fasted conditions.
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Protection of trial subjects |
This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki.
Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Oct 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
25
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Healthy male and female participants were enrolled at one site in Germany and were resident for a period of 5 days in each of 4 treatment periods. On day -1 of each treatment period, the subjects were admitted to the clinical unit and discharged on day 4. Ambulant visits occurred on days 5, 6, 7, 9 and 11. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants who fulfilled all eligibility criteria were randomized to 1 of 4 treatment sequences (in first treatment period only) following the William's design in this 4-period crossover study. There was a washout period of at least 14 days between treatment periods. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (Periods 1-4) (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
This is an open-label study.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1: ACBD | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 4. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered with food (dosing done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered with food (dosing was done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Arm title
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Treatment Sequence 2: BADC | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 4. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered with food (dosing done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered with food (dosing was done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Arm title
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Treatment Sequence 3: CDAB | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 4. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Granules for oral suspension
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered with food (dosing done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
YM178
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Other name |
Myrbetriq®, Betmiga™
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered with food (dosing was done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
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Arm title
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Treatment Sequence 4: DBCA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 4. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg oral suspension
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Investigational medicinal product code |
YM178
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other name |
Myrbetriq®, Betmiga™
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Granules for oral suspension
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
YM178
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other name |
Myrbetriq®, Betmiga™
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Film-coated tablet
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered under fasted conditions (overnight fast of at least 10 hours prior to dosing and 4 hours after dosing).
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg oral suspension
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
YM178
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other name |
Myrbetriq®, Betmiga™
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Granules for oral suspension
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Participants received a single dose of mirabegron 50 mg oral suspension on day 1 in one of 4 treatment periods, depending on their treatment sequence. Mirabegron was provided as granules and reconstituted with vehicle in bottle and was prepared into a modified release oral suspension 2 mg/mL and given to participants. Doses were administered with food (dosing done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mirabegron 50 mg modified release tablets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
YM178
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other name |
Myrbetriq®, Betmiga™
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Film-coated tablet
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Participants received a single dose of mirabegron 50 mg modified release tablet orally on day 1 in one of 4 treatment periods, depending on their treatment sequence. Doses were administered with food (dosing was done 30 minutes after completion of the light breakfast and a light lunch 2 hours after).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 1: ACBD
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 2: BADC
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 3: CDAB
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 4: DBCA
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Treatment Sequence 1: ACBD
|
||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 4. | ||
Reporting group title |
Treatment Sequence 2: BADC
|
||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 3 and a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 4. | ||
Reporting group title |
Treatment Sequence 3: CDAB
|
||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 1, a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 2, a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 4. | ||
Reporting group title |
Treatment Sequence 4: DBCA
|
||
Reporting group description |
Participants who received a single dose of 50 mg mirabegron modified release tablets administered under fed conditions (D) on day 1 of period 1, a single dose of 50 mg mirabegron oral suspension administered under fed conditions (B) on day 1 of period 2, a single dose of 50 mg mirabegron modified release tablets administered under fasted conditions (C) on day 1 of period 3 and a single dose of 50 mg mirabegron oral suspension administered under fasted conditions (A) on day 1 of period 4. | ||
Subject analysis set title |
Mirabegron Suspension Fasted
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants who received mirabegron 50 mg oral suspension under fasted conditions in 1 of 4 treatment periods, taken according to their treatment sequence.
|
||
Subject analysis set title |
Mirabegron Suspension Fed
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants who received mirabegron 50 mg oral suspension under fed conditions in 1 of 4 treatment periods, taken according to their treatment sequence.
|
||
Subject analysis set title |
Mirabegron Tablets Fasted
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants who received mirabegron 50 mg modified release tablets under fasted conditions in 1 of 4 treatment periods, taken according to their treatment sequence.
|
||
Subject analysis set title |
Mirabegron Tablets Fed
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants who received mirabegron 50 mg modified release tablets under fed conditions in 1 of 4 treatment periods, taken according to their treatment sequence.
|
|
|||||||||||||||||||||
End point title |
Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf) for Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was the pharmacokinetic analysis set (PKAS) which consisted of the subset of participants of the Safety Analysis Set (SAF) population (all randomized participants who received at least 1 dose of study drug) for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic (PK) parameter for the fasted mirabegron oral suspension and the fasted mirabegron tablet.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [1] - Participants with samples available |
|||||||||||||||||||||
Statistical analysis title |
Relative Bioavailability of Mirabegron | ||||||||||||||||||||
Statistical analysis description |
Relative bioavailability of mirabegron oral suspension formulation vs. tablets when dosed under fasted conditions. AUCinf was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect. The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Tablets Fasted v Mirabegron Suspension Fasted
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
47.95
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
40.91 | ||||||||||||||||||||
upper limit |
56.21 | ||||||||||||||||||||
Statistical analysis title |
Food Effect of Mirabegron Oral Suspension | ||||||||||||||||||||
Statistical analysis description |
Food effect of mirabegron oral suspension formulation. AUCinf was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect. The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Suspension Fasted v Mirabegron Suspension Fed
|
||||||||||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
40.12
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
33.95 | ||||||||||||||||||||
upper limit |
47.41 |
|
|||||||||||||||||||||
End point title |
Area Under the Concentration-time Curve from the Time of Dosing to the Last Measurable Concentration (AUClast) for Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Relative Bioavailability of Mirabegron | ||||||||||||||||||||
Statistical analysis description |
Relative bioavailability of mirabegron oral suspension formulation vs. tablets when dosed under fasted conditions. AUClast was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect.The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Suspension Fasted v Mirabegron Tablets Fasted
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
45.06
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
38.46 | ||||||||||||||||||||
upper limit |
52.8 | ||||||||||||||||||||
Statistical analysis title |
Food Effect of Mirabegron Oral Suspension | ||||||||||||||||||||
Statistical analysis description |
Food effect of mirabegron oral suspension formulation. AUClast was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect.The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Suspension Fasted v Mirabegron Suspension Fed
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
33.54
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
28.68 | ||||||||||||||||||||
upper limit |
39.23 |
|
|||||||||||||||||||||
End point title |
Maximum Concentration (Cmax) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population is PKAS.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Relative Bioavailability of Mirabegron | ||||||||||||||||||||
Statistical analysis description |
Relative bioavailability of mirabegron oral suspension formulation vs. tablets when dosed under fasted conditions. Cmax was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect. The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Suspension Fasted v Mirabegron Tablets Fasted
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
30.76
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
23.76 | ||||||||||||||||||||
upper limit |
39.81 | ||||||||||||||||||||
Statistical analysis title |
Food Effect of Mirabegron Oral Suspension | ||||||||||||||||||||
Statistical analysis description |
Food effect of mirabegron oral suspension formulation. Cmax was analyzed using a linear mixed effects model applied to the natural logarithm log-transformed PK parameter with treatment (suspension fasted, suspension fed, tablets fasted, tablets fed) and investigational period as fixed effects, and subject as a random effect. The number of participants analyzed is calculated by the system and cannot be changed; actual N=23.
|
||||||||||||||||||||
Comparison groups |
Mirabegron Suspension Fasted v Mirabegron Suspension Fed
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric Least Squares Mean Ratio | ||||||||||||||||||||
Point estimate |
22.4
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
17.35 | ||||||||||||||||||||
upper limit |
28.92 |
|
|||||||||||||||||||||
End point title |
Percentage of AUCinf Due to Extrapolation from Time to Last Measurable Concentration (tlast) to Time Infinity (AUC[%extrap]) for Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [2] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Apparent Total Systemic Clearance After Extravascular Dosing (CL/F) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [3] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Terminal Elimination Rate Constant (λz) for Mirabgron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [4] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Mean Residence Time from the Time of Dosing Extrapolated to Time Infinity (MRTinf) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [5] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Terminal Elimination Half-life (t1/2) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [6] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Time Prior to the Time Corresponding to the First Measurable (Nonzero) Concentration (tlag) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Time of Maximum Concentration (tmax) of Mirabgeron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Apparent Volume of Distribution During the Terminal Elimination Phase after Extravascular Dosing (Vz/F) of Mirabegron | ||||||||||||||||||||
End point description |
The analysis population was PKAS.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Day 1 predose, 30 minutes (min), 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h postdose
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [7] - Participants with samples available |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Participants with Adverse Events | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
An adverse event (AE) was assigned to the last treatment dose received prior to onset (or worsening). A treatment-emergent adverse event (TEAE) was defined as an adverse event which started after first administration of the study drug (day 1 of treatment period 1) up to the end-of-study visit (5 to 9 days after last [early] discharge from the clinical unit). Drug-related events can be possible or probable, as assessed by the investigator, or records where relationship is missing. The analysis population was SAF.
|
||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From first dose of study drug in first treatment period up to end of study visit in last treatment period (up to 95 days)
|
||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Palatability Visual Analogue Scale (VAS) Scores of Mirabegron (oral suspension) | |||||||||||||||||||||||||||||||||
End point description |
Palatability of mirabegron (oral suspension) was assessed using a VAS questionnaire, which consisted of 7 separate VAS scales (bitter, salty, sweet, sour, taste in general, aftertaste and acceptance) which were 100 mm in length (ranged from 0 mm “not at all” or "good" to 100 mm “very much” or "bad"). The analysis population was the SAF.
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End point type |
Secondary
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End point timeframe |
Day 1 postdose of each treatment period
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From first dose of study drug in first treatment period up to end of study visit in last treatment period (up to 95 days)
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Mirabegron Suspension Fed
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Reporting group description |
Participants who received mirabegron 50 mg oral suspension under fed conditions in 1 of 4 treatment periods, taken according to their treatment sequence. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mirabegron Suspension Fasted
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Reporting group description |
Participants who received mirabegron 50 mg oral suspension under fasted conditions in 1 of 4 treatment periods, taken according to their treatment sequence. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mirabegron Tablets Fasted
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Reporting group description |
Participants who received mirabegron 50 mg modified release tablets under fasted conditions in 1 of 4 treatment periods, taken according to their treatment sequence. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mirabegron Tablets Fed
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Reporting group description |
Participants who received mirabegron 50 mg modified release tablets under fed conditions in 1 of 4 treatment periods, taken according to their treatment sequence. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |